Anterior Cruciate Ligament InjuriesACLNCT05580133
All-Inside Single-Bundle for Anterior Cruciate Ligament Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft (ACL)
An observational study of Anterior Cruciate Ligament Injuries, run by Mongi Slim Hospital.
Trial summary
Anterior cruciate ligament reconstruction is the current gold standard for restoring knee stability. Hamstring tendon (HT) autograft is the most popular graft choice for ACL reconstruction worldwide. Read more about this study
- Who is it for?
- Ages 17 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2022to 10 Sep 2023
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: study population is a young athletic population with anterior laxity of the knee secondary to anterior cruciate ligament injury
Who may be able to join
- primary ACL rupture in adult patients
Who cannot join
- serious osteoarthritis
- revision cases
- multiple ligament injuries
- ankle injuries
About this study
Official title: All-Inside Single-Bundle for ACL Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft
Anterior cruciate ligament reconstruction is the current gold standard for restoring knee stability. Hamstring tendon (HT) autograft is the most popular graft choice for ACL reconstruction worldwide. Other autografts include bone-patellar tendon-bone and quadriceps tendon, yet no globally accepted gold standard of graft choice exists for use in ACL reconstruction.
The peroneus longus tendon (PLT) has been reported as an autograft choice for ligament reconstruction[2], but there is little information regarding the clinical outcomes using the peroneus longus tendon (AHPLT) compared with hamstring tendon autograft. Therefore, we are interested in investigating whether the clinical outcomes of the PLT autograft were equivalent to the Six-strand- hamstring tendon autograft.
Read the detailed description
prospective randomized clinical study to compare the results of all-inside anatomical ACL reconstruction using the AHPLT and using Six-strand- tendon autograft.
Randomization will be done with inclusion criteria of primary ACL rupture in adult patients and exclusion criteria of serious osteoarthritis, revision cases, and multiple ligament injuries.
Preoperatively, physical examinations including the anterior drawer test and the pivot shift Test were performed to judge the stability of the knee joint. All of the patients will be evaluated with an International Knee Documentation Committee (IKDC) 2000 subjective score, a Visual Analogue Scale (VAS), and an American Orthopedic Foot and Ankle Score (AOFAS).a knee joint arthrometers was also used with knee flexion of 30° at 134 N.
All of the tests will be performed three times by another experienced orthopedic surgeon who is not involved in the surgery, and the mean of the three measurements will be taken as the final value.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- anterior cruciate ligament reconstruction
- Keywords
- anterior cruciate ligament, peroneus longus tendon, Hamstring Tendons, donor site
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior cruciate ligament reconstructionProcedure or surgery
Arthroscopic reconstruction of the anterior cruciate ligament is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore function after injury.
| Study group | Role | What they receive |
|---|---|---|
| Peroneus Longus Tendon autograft | All-Inside Single-Bundle for ACL Reconstruction with Full Thickness of the Peroneus Longus Tendon Receives: Procedure: anterior cruciate ligament reconstruction | |
| six-strand-hamstring autograft | All-Inside Single-Bundle for ACL Reconstruction with six-strand-hamstring autograft Receives: Procedure: anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
the anterior drawer test
the anterior drawer test is used to assess the integrity of the anterior cruciate ligament. With the knee flexed to 90 degrees, the foot is stabilized by sitting on it. The proximal tibia is grasped firmly with both hands, and the tibia is forcibly pulled anteriorly, noting any or abnormal movement compared with the opposite side.
to estimate how severe the injury is by how far they can displace the ACL. They grade the tear from one to three (I, II, or III), with three being the worst tear. A grade I tear moves 5 millimeters, a grade II tear moves between 5 and 10 millimeters, and a grade III tear moves more than 10 millimeters.
Measured: Baseline,
the anterior drawer test
the anterior drawer test is used to assess the integrity of the anterior cruciate ligament. With the knee flexed to 90 degrees, the foot is stabilized by sitting on it. The proximal tibia is grasped firmly with both hands, and the tibia is forcibly pulled anteriorly, noting any or abnormal movement compared with the opposite side.
to estimate how severe the injury is by how far they can displace the ACL. They grade the tear from one to three (I, II, or III), with three being the worst tear. A grade I tear moves 5 millimeters, a grade II tear moves between 5 and 10 millimeters, and a grade III tear moves more than 10 millimeters.
Measured: Month 8
The pivot shift
The pivot shift is a dynamic but passive test of knee stability, carried out by the examiner without any activity of the patient. It shows a dysregulation between rolling and gliding in the knee joint. The patient lies in supine. The movement is a combination of axial load and valgus force, applied by the examiner, during a knee flexion from an extended position. When the test is positive, it indicates an injury of the anterior cruciate ligament
Measured: Baseline
The pivot shift
The pivot shift is a dynamic but passive test of knee stability, carried out by the examiner without any activity of the patient. It shows a dysregulation between rolling and gliding in the knee joint. The patient lies in supine. The movement is a combination of axial load and valgus force, applied by the examiner, during a knee flexion from an extended position. When the test is positive, it indicates an injury of the anterior cruciate ligament
Measured: Month 8
Visual Analogue Scale (VAS)
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: Baseline
Visual Analogue Scale (VAS)
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: Week 3
International Knee Documentation Committee (IKDC) 2000 subjective score
The score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
Measured: Baseline
International Knee Documentation Committee (IKDC) 2000 subjective score
The score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
Measured: Month 8
knee joint arthrometers
a value less than 3 mm means that there is no ACL injury difference residing between 3 and 5 mm, it is considered that anterior posterior laxity is unusually high. The ACL might therefore be partially or completely torn.
difference higher than 5 mm, it is considered that anterior posterior laxity is very high which indicates a complete ACL tear.
Measured: Baseline
knee joint arthrometers
a value less than 3 mm means that there is no ACL injury difference residing between 3 and 5 mm, it is considered that anterior posterior laxity is unusually high. The ACL might therefore be partially or completely torn.
difference higher than 5 mm, it is considered that anterior posterior laxity is very high which indicates a complete ACL tear.
Measured: Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start10 Oct 2022 (estimated)
- Primary completion10 Aug 2023 (estimated)
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed hedi ezzine, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580133
- Sponsor's protocol ID
- mongislim
- Acronym
- ACL
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-Inside Single-Bundle for ACL Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft
- ClinicalTrials.gov ID
- NCT05580133
- Acronym / sponsor ID
- ACL / mongislim
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior cruciate ligament, peroneus longus tendon, Hamstring Tendons, donor site
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 10 Aug 2023 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anterior cruciate ligament reconstruction is the current gold standard for restoring knee stability. Hamstring tendon (HT) autograft is the most popular graft choice for ACL reconstruction worldwide. Other autografts include bone-patellar tendon-bone and quadriceps tendon, yet no globally accepted gold standard of graft choice exists for use in ACL reconstruction.
The peroneus longus tendon (PLT) has been reported as an autograft choice for ligament reconstruction[2], but there is little information regarding the clinical outcomes using the peroneus longus tendon (AHPLT) compared with hamstring tendon autograft. Therefore, we are interested in investigating whether the clinical outcomes of the PLT autograft were equivalent to the Six-strand- hamstring tendon autograft.
Detailed description
prospective randomized clinical study to compare the results of all-inside anatomical ACL reconstruction using the AHPLT and using Six-strand- tendon autograft.
Randomization will be done with inclusion criteria of primary ACL rupture in adult patients and exclusion criteria of serious osteoarthritis, revision cases, and multiple ligament injuries.
Preoperatively, physical examinations including the anterior drawer test and the pivot shift Test were performed to judge the stability of the knee joint. All of the patients will be evaluated with an International Knee Documentation Committee (IKDC) 2000 subjective score, a Visual Analogue Scale (VAS), and an American Orthopedic Foot and Ankle Score (AOFAS).a knee joint arthrometers was also used with knee flexion of 30° at 134 N.
All of the tests will be performed three times by another experienced orthopedic surgeon who is not involved in the surgery, and the mean of the three measurements will be taken as the final value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peroneus Longus Tendon autograft | – | Procedure: anterior cruciate ligament reconstructionAll-Inside Single-Bundle for ACL Reconstruction with Full Thickness of the Peroneus Longus Tendon |
| six-strand-hamstring autograft | – | Procedure: anterior cruciate ligament reconstructionAll-Inside Single-Bundle for ACL Reconstruction with six-strand-hamstring autograft |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- study population is a young athletic population with anterior laxity of the knee secondary to anterior cruciate ligament injury
Key inclusion criteria (1 listed)
- primary ACL rupture in adult patients
Key exclusion criteria (4 listed)
- serious osteoarthritis
- revision cases
- multiple ligament injuries
- ankle injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior cruciate ligament reconstructionArthroscopic reconstruction of the anterior cruciate ligament is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore function after injury. | Procedure or surgery | Peroneus Longus Tendon autograft, six-strand-hamstring autograft |
Primary outcome
the anterior drawer test
Time frame: Baseline,
the anterior drawer test is used to assess the integrity of the anterior cruciate ligament. With the knee flexed to 90 degrees, the foot is stabilized by sitting on it. The proximal tibia is grasped firmly with both hands, and the tibia is forcibly pulled anteriorly, noting any or abnormal movement compared with the opposite side. to estimate how severe the injury is by how far they can displace the ACL. They grade the tear from one to three (I, II, or III), with three being the worst tear. A grade I tear moves 5 millimeters, a grade II tear moves between 5 and 10 millimeters, and a grade III tear moves more than 10 millimeters.
the anterior drawer test
Time frame: Month 8
the anterior drawer test is used to assess the integrity of the anterior cruciate ligament. With the knee flexed to 90 degrees, the foot is stabilized by sitting on it. The proximal tibia is grasped firmly with both hands, and the tibia is forcibly pulled anteriorly, noting any or abnormal movement compared with the opposite side. to estimate how severe the injury is by how far they can displace the ACL. They grade the tear from one to three (I, II, or III), with three being the worst tear. A grade I tear moves 5 millimeters, a grade II tear moves between 5 and 10 millimeters, and a grade III tear moves more than 10 millimeters.
The pivot shift
Time frame: Baseline
The pivot shift is a dynamic but passive test of knee stability, carried out by the examiner without any activity of the patient. It shows a dysregulation between rolling and gliding in the knee joint. The patient lies in supine. The movement is a combination of axial load and valgus force, applied by the examiner, during a knee flexion from an extended position. When the test is positive, it indicates an injury of the anterior cruciate ligament
The pivot shift
Time frame: Month 8
The pivot shift is a dynamic but passive test of knee stability, carried out by the examiner without any activity of the patient. It shows a dysregulation between rolling and gliding in the knee joint. The patient lies in supine. The movement is a combination of axial load and valgus force, applied by the examiner, during a knee flexion from an extended position. When the test is positive, it indicates an injury of the anterior cruciate ligament
Visual Analogue Scale (VAS)
Time frame: Baseline
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Visual Analogue Scale (VAS)
Time frame: Week 3
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
International Knee Documentation Committee (IKDC) 2000 subjective score
Time frame: Baseline
The score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
International Knee Documentation Committee (IKDC) 2000 subjective score
Time frame: Month 8
The score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
knee joint arthrometers
Time frame: Baseline
a value less than 3 mm means that there is no ACL injury difference residing between 3 and 5 mm, it is considered that anterior posterior laxity is unusually high. The ACL might therefore be partially or completely torn. difference higher than 5 mm, it is considered that anterior posterior laxity is very high which indicates a complete ACL tear.
knee joint arthrometers
Time frame: Month 8
a value less than 3 mm means that there is no ACL injury difference residing between 3 and 5 mm, it is considered that anterior posterior laxity is unusually high. The ACL might therefore be partially or completely torn. difference higher than 5 mm, it is considered that anterior posterior laxity is very high which indicates a complete ACL tear.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by Mongi Slim Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the anterior drawer test (time frame: Baseline,). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.